MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-04

Device Problems Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing no lock.Device testing could not be performed due to no lock.Revision surgery is scheduled.

Manufacturer Narrative

Additional information: d.10.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed damaged sliced silicone overmold on the electrode lead.This is believed to have occurred during revision surgery.In addition, dents were observed on the bottom cover of the device.The photographic imaging inspection revealed electrical components dislodged from the hybrid.System lock could not be obtained at any spacing.The electrode and no lock condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis revealed cracked conductive epoxy at the feedthru pin connection on some pins.In addition, a crack along the substrate.The reported complaint of loss of lock with the device was verified during this analysis.The device was received with multiple cracks along the hybrid and dislodged electrical components.A corrective action was implemented.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10327147
• MDR Text Key: 201578932
• Report Number: 3006556115-2020-00663
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)160816(17)190731
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2020; 09/08/2020; 10/13/2020; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR